Ruggieri, L, Giannuzzi, V, Baiardi, P, Bonifazi, F, Davies, E H, Giaquinto, C, Bonifazi, D, Felisi, M, Chiron, C, Pressler, R, Rabe, H, Whitaker, M J, Neubert, A, Jacqz-Aigrain, E, Eichler, I, Turner, M A, Ceci, A and on behalf of the GRiP Consortium, (2015) Successful private–public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines. European Journal of Pediatrics, 174 (4). pp. 481-491. ISSN 0340-6199

Preview

PDF - Published Version Download (648kB) | Preview

Abstract

The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly
available sources have been consulted and a descriptive
analysis has been performed. Twenty Research Consortia
including 246 partners in 29 European and non-European
countries were created (involving 129 universities or public funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMAPaediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres.
Conclusion: Notwithstanding the EU contribution for each
study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private–public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of offpatent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

Item Type:	Article
Keywords:	Paediatric clinical trials – Seventh Framework Programme – Drug development – PUMA
Schools and Departments:	Brighton and Sussex Medical School > Clinical and Experimental Medicine
Subjects:	R Medicine > RJ Pediatrics > RJ0251 Newborn infants Including physiology, care, treatment, diseases
Depositing User:	Judy Keogh
Date Deposited:	29 Sep 2014 13:33
Last Modified:	02 Jul 2019 17:50
URI:	http://sro.sussex.ac.uk/id/eprint/50400

View download statistics for this item

📧 Request an update